MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-17 for PREPIERCED MALE ADAPTER PLUG 11301 manufactured by Hospira De Costa Rica Ltd..
[697228]
General report received of an unspecified number of undocumented incidents of leaks; subsequently blood loss was noted. The customer contact reported that the male adapter plugs were connected to the patients' catheters. After unspecified lengths of time in use, the nurses reported that the male adapter plugs leaked a "small amount of blood" at the catheter connections. The male adapter plugs were either replaced or iv tubing sets were connected directly to the catheter hubs and the therapies were resumed. There were no reported adverse patient effects. No medical interventions were reported. Though requested, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[8124792]
The customer indicated that the devices were discarded. Representative devices from the same lot are expected to be returned for investigation. They have not yet been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615050-2007-00095 |
| MDR Report Key | 914392 |
| Report Source | 05 |
| Date Received | 2007-09-17 |
| Date of Report | 2007-08-16 |
| Date of Event | 2007-08-01 |
| Date Mfgr Received | 2007-08-16 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2007-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN COX, DIRECTOR |
| Manufacturer Street | 8401 WEST 102ND ST, STE 300 DEPT # 097U, BLDG #HW1 |
| Manufacturer City | PLEASANT PRAIRIE WI 53158 |
| Manufacturer Postal | 53158 |
| Manufacturer Phone | 2625776072 |
| Manufacturer G1 | HOSPIRA DE COSTA RICA LTD. |
| Manufacturer Street | ZONA FRANCA GLOBAL |
| Manufacturer City | LA AURORA DE HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREPIERCED MALE ADAPTER PLUG |
| Generic Name | 79-GCE |
| Product Code | GCE |
| Date Received | 2007-09-17 |
| Model Number | NA |
| Catalog Number | 11301 |
| Lot Number | 351965H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 894083 |
| Manufacturer | HOSPIRA DE COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA DE HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-17 |